ML20149K772

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Forwards marked-up Copy W/Comments,Final Rule That Further Clarifies Standards for Protection Against Radiation
ML20149K772
Person / Time
Issue date: 01/11/1995
From: Lesar M
NRC OFFICE OF ADMINISTRATION (ADM)
To: Mccausland J
NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
Shared Package
ML20149C780 List:
References
FRN-61FR52388, RULE-PR-20, RULE-PR-32, RULE-PR-35, RULE-PR-36, RULE-PR-39 AF46-1-016, AF46-1-16, NUDOCS 9707300141
Download: ML20149K772 (23)


Text

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% E UNITED STATES l}F- 46 -1.

{g gff NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001

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January 11, 1995

'l MEMORANDUM T0: Jayne McCausland Off of c1 ar Regu ory Research j

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FROM: c ael . Lesar, Ch ef Rules Review Section Rules Review and Directives Branch Division of Freedom of Information l and Publications Services Office of Administration

SUBJECT:

REVIEW OF FINAL RULE ENTITLED " STANDARDS FOR j PROTECTION AGAINST RADIATION; FURTHER CLARIFICATION" j i

The Rules Review Section has reviewed the final rule that further clarifies  !

the standards for protection against radiation. We have attached a marked  !

copy of the rule that presents our comments.

When the document is forwarded for publication, please include a 3.5 inch diskette that contains a copy of the document in Wordperfect 5.0 or 5.1 as part of the transmittal package. The diskette will be forwarded to the Office of the Federal Register and the Government Printing Office for their use in typesetting the document.

lIf you have any questions concerning this rule, please contact Alice Katoski on 415-6862, or me~on 415-7163.

Attachment:

As stated

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9707300141 970711 PDR PR 20 61FR52388 PDR

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[7590-01-P]

NUCLEAR REGULATORY COMMISSION 10 CFR PARTS 2, 20, 32, AND 36 RIN 3150-AA38 Standards for Protection Against Radiation; Further clerification AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule; further clarification.

SUMMARY

On May 21, 1991, a final rule was published in the Federal Register (56 FR 23300) that amended 10 CFR Part 20 to include the NRC's revised standards for protection against radiation, k bsequent amendments

, were published to (1) change the mandatory implementation date to January 1, 1994, and make conforming changes to the text to reflect the new implementation date (57 FR 38588), (2) remove or modify provisions to reflect the new implementation date for NRC's revised standards for radiation protection (58 FR 67657), and (3) restore provisions inadvertently removed or ,

/r nmrs o4/

modified by action described in (2), above [ This document M to make

/-furtherminorcorrectionsandclarifyingchangestotheNRC'sstandardsfor protection against radiation.

EFFECTIVE DATE: (Date of publication in the Federal Register).

FOR FURTHER INFORMATION CONTACT: Jayne M. McCausland, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6219.

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l SUPPLEMENTARY INFORMATION:

This final rule makes minor corrections and clarifying changes to 10 CFR Parts 2, 20, 32, and 36 as follows: . #M # /7 m" b d /'"'" # 9' h C b e h oai' / % / 3 s ate a<r> n,/,/ l (1) [nAppendixCtoPart2 f-EG.1101(d) = d (e)-, Ay <r rew,' -

, AUIHORITY: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930 933, 935, 936, 937, 948, 953, 955, as amended (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236), secs. 201, as amended, 262, 206, 88 Sta; 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

4. In 10 CFR 20.1003, remove the definitions Airborne radioactivity area and Eve dose eauivalent. The definitions Airborne radioactive material area, Lens dose eauivalent, and Submersion dose are added, and the definition of Annual limit on intake, Declared oreanant woman, Derived air concentratio

.@A_C_l, High radiation area, Individual monitorino devices, anJ Very hiah radiation area are revised in alpnacetical order to read as follows:

s s 20.1003 Definitions.

Airborne radioactive materials area means a room, enclosure, or area ii, which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations --

(1) In excess of the derived air concentrations (DAC's) specified in appendix B to ss 20.1001-20.2402, or 1

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{ (2) To .such a degree that an individual present in the area without j respiratory protective equipment, could exceed, during the hours an individual j is present in a week, an intake (or an external exposure of 30 mR for the car.,

of submersion dose) of 0.6 percent of the annual limit on intake (ALI) or 12 3 DAC-hours.

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Annual limit on intake (ALI) means the derived limit for the amount of i radioactive material taken into the body of an adult worker by inhalation or  !

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ingestion in a year. ALI is the smaller value of intake of a jiven j radionuclide in a year by the reference man that would result in a committed l effective dose equivalent of 5 rems (0.05 Sv) or a committed tuse equivalent of 50 rems (0.5 Sv) to any individual organ or tissue. (ALI values for intake  ;

by ingestion and by inhalation of selected radionuclides are given in Table 1, Columns 1 and 2, of appendix B to SS 20.1001-20.2402.)  !

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Declared creanant woman means a woman who has voluntarily informed the f license her employer, in writing, of her pregnancy and the estimated date t conception.

Derived air concentration (DAC) means the concentration of a given radionuclide in air which, if breathed by the reference man for a working yes of 2,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> under conditions of light work (inhalation rate 1.2 cubic meters of air per hour), results in an intake of one ALI or, in the case of submersion in a cloud of radioactive material, presence in the atmosphere for 2,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> per year will produce a dose equivalent of 5 rems from external exposure. DAC values are given in Table 1, Column 3, of appendix B to f6 20.1001-20.2402.

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Hiah radiation area means an area, accessible to indivicaals, in which radiation levels from external sources could result in an individual receivim, l a dose equivalent in excess of 0.1 rem (1 mSv) in 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> at 30 centimeters i

from the radiation source or from any surface that the radiation penetrates.

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i. Individual monitorina devices (individual monitoring equipment) means

!. devices designed to be worn by a single individual for the assessment of dost I '

equivalent such as film badges, thermoluminescense dosimeters (TLDs), pocket ionization chambers, or devices designed to be worn by a single individual f; the assessment of committed effective dose equivalent, such at personal

(" lapel") air sampling devices.

Lens dose eauivalent applies to the external exposure of the lens of 11 eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cma ),

1 Submersion dose is the dose received from external sources resulting from being submerged in a cloud of radioactive material.

I Very high radiation area means an area, accessible to individuals, in which radiation levels from external sources could result in ca individual 1

receiving an absorbed dose in excess of 500 rads (5 grays) in i hour at 1 '

meter from a radiation source or from any surface that the ra :ation  !

penetrates.

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s 20.1101 [ Amended]

5. In s 20.1101, paragraph (b) is amended by deleting the word

" practicable" and replacing it with the word " practical."

l 6 20.1201 [ Amended]

6. In s 20.1201, paragraphs (d) and (e) are amended L/ revising the l reference to "ss 20.1001-20.2401" to read "ss 20.1001-20.240?."

s 20.1203 [ Amended]

7. Section 20.1203 is amended by revising the reference to "ss 20.1001-20.2401" to read "ss 20.1001-20.2402."

s 20.1204 [ Amended]

8. In s 20.1204, paragraphs (c)(3), (e)(1), and (h)(E> are amended ,

revising the reference to "ss 20.1001-20.2401" to read "ss 20.1001-20.2402."

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9. In s 20.1206, paragraph (a) is revised to read as rollows:

l s 20.1206 Planned special exposures.

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(a) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the clditional exposure are unavailable or impractical.

10. In s 20.1208, paragraphs (a)

A (c)\and(d)arere..sedtoreade follows:

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, 5 20.1208 Dose to an embryo / fetus.

(a) The licensee shall ensure that the embryo / fetus dose equivalent during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). (For recordkeeping requirements, see 5 20.2106.)

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, (c) The embryo / fetus dose equivalent shall be taken as the sum of--

(1) * *

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  • A (d) If the embryo / fetus dose equivalent is found to have exceeded 0.'

l rem (5 mSv), or is within 0.05 rem (0.5 mSv) of this dose, by the time the woman declares the pregnancy to the licensee, the licensee shall be deemed ti be in compliance with paragraph (a) of this section if the adcitional dose t-the embryo / fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.

s20.1302 [ Amended]

l 11. In s 20.1302, paragraphs (b)(2)(i) and (c) are amended by revisir i

the reference to "Es 20.1001-20.2401" to read "6% 20.1001-20.1 02."

12. ' . . s 20.1501, paragraphs (a)(2)(1) and (a)(2)(iii are revised
  • read as follows:

20.1501 General.

, (a)

(2) j (i) The magnitude and extent of radiation levels; and 4

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(iii)Yhe current and potential radiological hazards that could be l 1

present.

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13. In s 20.1502, the introductory text of paragraph (a), and i

paragraphs (a)(2), (b)(1), and (b)(2) are revised as follows:

s 20.1502 Conditions requiring individual monitoring of external and l internal occupational dose.

(a) Each licensee shall monitor occupational exposure i > radiation fi sources under control of the licensee and shall supply and resaire the use o l

individual monitoring devices by --

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i (2) Minors likely to receive, in 1 year from sources e. ernal to the body, a dose in excess of 10% of the limit in s20,1207, and (b)

(1) Adults likely to receive,.in 1 year, an intake in excess of 10 percent of the applicable ALI(s) in table 1, Columns 1 and 2, of appendix B l ss 20.1001-20.2402.  !

l (2) Declared pregnant women likely to receive, during 1 entire l pregnancy, from external sources, a dose in excess of 10% of .e applicable i l limit in 5 20.1208.

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s 20.1701 [lo iended)

14. Section 20.1701 is amended by deleting the word ", acticable" an.

replacing it with the word " practical."

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5 20.1702 [ Amended]

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15. Scctic, 20.1702 is amended by deleting the word ";cacticable" an replacing it with the word " practical."
16. In S 20.1703, paragraph (b)(1), the introductory i 2xt of paragri (b)(2), and paragraph (d) are revised to read as follows:

s 20.1703 Use of individual respiratory protection equipment.

(b)

(1) The licensee selects respiratory protection equipnr at that provic a protection factor (see appendix A to ss 20.1001-20.2402) griiter than the multiple by which peak concentrations of airborne radioactive materials in t.

working area are expected to exceed the values specified in a, ,endix B to ss 20.1001-20.2402, table 1, column 3. If the selection of a cespiratory ,

1 protection device with a protection factor greater than the n. .tiple defineo )

in the preceding sentence is inconsistent with the goal speci :ed in s 20.17 of keeping the total effective dose equivalent ALARA, the liceasee may select respiratory protection equipment with a lower protection facto, only if such selection Would result in keeping the total effective dose eqt.ivalent ALARA.

The concentration of radioactive material in the air that is .. haled when respirators are worn may be initially estimated by dividing t. average concentration in air, during each period of uninterrupted use. by the protection factor. If the exposure is later found to be great ar than estimated, the corrected value must be used; if the exposure i, later found be less than estimated, the corrected value may be used. i (2) The licensee shall obtain authorization from the C ..nission befoi assigning respiratory protection factors in excess of those s cified in

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l i appendix A to ss 20.1001-20.2402. The Commission may authorize a licensee tt use higher protection factors on receipt of an application that --

(d) The licensee shall notify the Regional Administrat ar, in writing.

f of the appropriate NRC Regional Office listed in appendix D to ss 20.1001-20.2402 at laast 30 days before the date that respiratory protection equipme, is first used under the provisions of either s 20.1703(a) or (a).

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s 20.1704 [ Amended) 1 S
17. u, s 20.1704, the introductory paragraph is ameout . by revising i
f. the reference to "ss 20.1001-20.2401" to rea'd "ss 20.1001-20.4 ;02."
s 20.1902 [An.anded]

] 18. In s 20.1902, paragraph (e) is amended by revising the reference J

! to "ss 20.1001-20.2401" to read "s 20.1001-20.2402."

5 20.1905 [ Amended]

j 19. In s 20.1905, paragraphs (a) and (b) are amended i/ revising the reference to "ss 20.1001-20.2401" to read "ss 20.1001-20.2402.

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s 20.1906 [ Amended) i
20. In s 20.1906, paragraph (c) is amended by deletint the word i

" practicable" and replacing it with the word " practical."

21. '

5 20.1906, paragraph (d) is amended by revisir. the referc...

to "ss 20.1001-20.2401" to read "sG 20.1001-20.2402."

s 20.2003 [ An. roded]

22. In s 20.2003, paragraphs (a)(2) and (a)(3)(1) are amended by revising the reference to "ss 20.1001-20.2401" to read "ss 20.1001-20.2402."

s 20.2006 [ Amended]

23. In s 20.2006, paragraphs (a), (b), (c), and (d) e. amended by revising the reference to "ss 20.1001-20.2401" to read "ss 20, 001-20.2402."

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24. In s 20.2101, (b) is redesignated as paragraph (c; and revised, and a new paragraph (b) is added to read as follows:

s 20.2101 General provisions.

(b) The licensee may indicate in parenthesis the SI Units, but the

quantitative reporting must be done as stated in paragraph (a) of this section.

(c) '1ne licensee shall make-a clear distinction among .he quantIUe:

entered on the records required by this part (e.g., total eff Live dose equivalent, shallow-dose equivalent, lens dose equivalent, de -dose equivalent, committed effective dose equivalent).

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I 25. In S 20.2106, paragraphs (a)(2) and (a)(3) are re ised to read c g

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' s 20.2106 Records of individual monitoring results.

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(2) The estimated intake of radionuclides (see s 20.1;;2); and (3) The committed effective dose equivalent assigned ta the intake o radionuclides; and s 20.2201 (Amended]

26. In 5 20.2201, paragraphs (a)(i), (a)(ii), and (b) )(ii) are amenu,-d by re ising the reference to "ss 20.1001-20.2401" to ad "ss 20.10t 20.2% 2."

s 20.2203 [Am.:nded)

27. In s 20.2203, paragraph (d) is amended by revisin the reference to "ss 20.1001-20.2401" to read "ss 20.1001-20.2402."

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6 20.2204 [ Amended) l 28. Section 20.2204 is amended by revising the referenu to

"$9 20.1001-20.2401" to read "99 20.1001-20.2402."
29. InAppendixAtoPart20, footnotes /d.through(INerevisedto

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Appendix A to Part 20 - Protection Factors for Respirators  ;

Footnotes j

} d.l. The protection factor is a measure of the degree of protection afforded by a respirator, defined as the ratio of the concent, . tion of 2

airborne radioactive material outside the respiratory protect. e equipment i 1

i that inside the equipment (usually inside the facepiece) unde, conditions vi use. It is applied to the ambient airborne concentration to i;timate the I concentrations inhaled by the wearer according to the followii; formula:

4 Ambient airborne Concentration = concentration inhaled Protection factor  ;

} 1 l 2. The protection factors apply:

i i i -9) Only for individuals trained in using respirators ..nd wearing i properly fitted respirators that are used and maintained under supervision is j a well-planned respiratory protective program. l 1 il  %) For air-purifying respirators only when high effi iency

}i - particulate filters (above 99.97% removal efficiency by thern. :ly generatea 0.3 pm dioctyl phthalate (DOP) test or equivalent) are used i; atmospheres :

deficient in oxygen and not containing radioactive gas or vaps respiratory hazards.

i fit W No adjustment is to be made for the use of sorben against l

i radioactive material in the form of gases or vapors.

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@ For atmosphere-supplying respirators only when supplied with adequate respirable air. Respirable air shall be provided of the quality an .

quantity required in accordance with NIOSH/MSHA certification (described in CFR part 11). Oxygen and air shall not be used in the same a,,aratus, l I'

e. Excluding radioactive contaminants that present a. absorption or submersion hazard. For tritium oxide, approximately one-thir. of the intake occurs by absorption through the skin so that an overall prot <; tion factor o less than 3 is appropriate when atmosphere-supplying respirat,cs are used to protect again,t Leitium oxide. If the protection factor for , device is 5, the ef fective protection factor for tritium is about 2.1; fue .evices wi u protection factors of 10-, the effective factor for tritium 04 .e is about 2. j i

and for devices with protection factors of 100 or more, the etiective factor i for tritium oxide is about 2.94. Air-purifying respirators at a not suitable for protection against tritium oxide. See also footnote i. ct icerning supplied-air suits,

f. Canisters and cartridges shall not be used beyoni. ,ervice-life limitations, i

1 9 Under-chin type only. This type of respirator is ,ot satisfactc for u m where it might be possible (e.g., if an accident or e. rgency were i occur; for ti.; an.bient airborne concentrations to reach insta, ;.aneous value:

great or than 10 t imes the pertinent values in table 1, colunu. of appencia to b J0.lbu;-2u 2402 of this part. This type of respirator not suitabl<

for protection against plutonium or other high-toxicity mater, .ls. The masi.

is to be tested for fit prior to use, each time it is donned.

n.l. Equipment shall be operated in a manner that ensui>s that propei air f.ow-rates are maintained. A protection factor of no mor. than 1000 ma.,

be utilized for tested-and-certified supplied-air hoods when minimum air li

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i ~ flow of 6 cubic feet (0.17 cubic meters) per minute is mainta.. ed and i calibrated air-line pressure gauges or flow measuring devices are used. A.

. protection factor of up to 2000 may be used for tested and cescified hoods l

only when the air flow is maintained at the manufacturer's ret;mmended maxino '
rate for the equipment, this rate is greater than 6 cubic fee < (0.17 cubic a

meters) per minute, and calibrated air-line pressure gauges os flow measurin s

j devices are used.

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, ;2. The design of the supplied-air hood or helmet (wita a minimum fl

! of 6 cfm (0.17 m3 per minute) of air) may determine its overa efficiencj t 1

j the protection it provides. For example, some hoods aspirate ontaminated into <ne breathing zone when the wearer works with hands-ove. aad. Th i:.

l j aspiration may be overcome if a short cape-like extension to .e hood is ..u.

j under a coat or overalls. Other limitations specified by the spproval agenc shall be considered before using'a hood in certain types of at.,ospheres (see footnote 1). l

i. Appropriate protection factors shall be determine; taking into account the design of the suit and its permeability to the co aminant unoer conditions of use. There shall be a standby rescue person e4 .pped with a respirator or other apparatus appropriate for the potential h_.rds and communications equipment whenever supplied-air suits are used.
j. No approval schedules are currently available for .his equipn.co.

Equir.ent is to L.e evaluated by testing or on the basis of re able test inik 4 tion.

k. Inis type of respirator may provide greater prots ion and be u as an emergencj cevice in unknown concentrations for protecti. against l inhalation hazards. External radiation hazards and other limitations to

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{ permitted exposure, such as skin absorption, must be taken ira a account in I

such circumstances.

1. Quantitative fit testing shall. be performed on eat a individual, j and no more than 0.02% leakage is allowed with this type of a, aratus.

Perceptible outward leakage of gas from this or any positive , essure self-i contained breathing apparatus is unacceptable because service ,ife will be j

. reduced substantially. Special training in the use of this tu e of apparatu j shall be provided to the wearer.

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l 30. In Appendix C, the quantity for Carbon-14 is revi :d as follows:

! I Appenaix C to Part 20 l i  ;

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Carbon-14 ,..., 100 2

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  • b l Appendix F to Part 20 [ Amended)
31. In Appendix F, paragraph I. Manifest is amended b., deleting the word " practicable" and replacing it with the word " practical .

I PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTUL. OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATE: AL

j. 32. The authority citation for Part 32 continues to r..d as follows:

! Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948 ,53, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat 1242, as t

l amended (42 U.S.C. 5841).

1 j s 32.54 [ Amended) j 33. In s 32.54, paragraph (a) is amended by revising e reference t i

j "s 20.203(a)" to read "s 20.1901."

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l PART 36 -- LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS

34. The authority citation for part 36 continues to r id as follows:

Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 335, 948, 953, ,

954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 L.S.C. 2111,  ;

2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as amended, 2t ', 206, 88 Sta 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

35. In Q 36.23, paragraph (g) is revised to read as ; lows:

9 36.23 Access control.

(g) i.ch entrance to the radiation room of a panorami irradiator ai, each entrance to the area within the personnel access barrier >f an underwat.

irradiator must have a sign bearing the radiation symbol and ,e words,

" Caution (or danger) radioactive material." Panoramic irradi ors must als.

have a sign stating "Very High Radiation Area," but the sign y be r: moved, covered, or otherwise made inoperative when the sources are t..ly shielded.

Dated at Rockville, Maryland, this day of 199 .

For the Nuclear Regulato: :ommission.

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James M. Taylor, Executive Director for op ations.

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